Non-surgical initial therapy for intussusception in infants and children has generally constituted hydrostatic reduction under fluoroscopic control using barium or other appropriate water-soluble contrast media. While air reduction of intussusception has long been known and reported, only recently has it gained popularity as an alternative to hydrostatic reduction, having been found to be a more efficient and faster procedure. This, in turn, results in less exposure to radiation both for the patient and the operator. Furthermore, in general, better results have been achieved with air reduction, as compared to hydrostatic reduction.
Prior art workers have devised a number of intussusception air reduction systems. These systems are generally characterized by complexity and awkwardness in operation. They employed various types of gauge devices ranging from mercury manometer systems to sphygmomanometric aneroid gauges. They also employed various types of mechanical and hand-operated air pumping devices. The prior art systems lack the control and simplicity of the present system, and could subject the operator to excessive doses of radiation.
The present invention is based upon the discovery that air reduction of intussusception can be easily and quickly accomplished by a simple and relatively inexpensive system. Unlike the prior art systems, the system of the present invention is hand-held and can be completely operated by one hand of the operator. The system can be held and actuated by either the right or left hand of the operator. The various steps of the procedure are controlled by a lever-actuated three-way stopcock. The lever is controlled in trigger-like fashion by the index finger of the hand holding the system. Unlike hydrostatic systems, the air system of the present invention permits instantaneous decompression by simple manipulation of the above-mentioned index finger. This constitutes an important safety factor. Instantaneous decompression can safely be achieved without contamination, as will be described hereinafter.
Not only can the entire system of the present invention be operated with one hand, but since it is entirely hand-held, it can be operated and held at any level which is preferred by the operator, a level which increases control during the reduction procedure. This is important since the operator can hold the device such that he is able to simultaneously monitor intra-colonic pressure, monitor the reduction procedure on the video monitor, operate the device (insufflate air/decompress as necessary), and control the patient and fluoroscopic tower during the reduction procedure. No other previously described system allows the total control afforded in this design. This control not only simplifies the procedure for more efficiency, but also serves as an important safety element, since improved control over the entire reduction procedure translates into improved safety and fewer unexpected complications.
The single-handed, hand-held operation provides for improved radiation safety, since it allows the radiologist to stand as close to or as far from the radiation source (fluoroscopy table) as desired. This feature is allowed by the tubing length and the one-handed operation design.
As an added safety measure, all embodiments of the present invention may be provided with a pop-off valve, if desired. The air reduction system of the present invention is made up of two basic parts: an insufflator portion and a tube portion, as will be set forth hereinafter. In some embodiments the tube portion is disposable and replaceable. In other embodiments, the entire air reduction system is disposable.